FDA Guide To Investigate OOS PDF

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Investigating Out of Specification

(OOS) Test Results for
Pharmaceutical Production
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TABLE OF CONTENTS
I.
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
II.
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
III.
IDENTIFYING AND ASSESSING OOS TEST RESULTS . . . . . . . . . . . . . . . . . . . . . 2
IV.
V.
A.
Responsibility of the Analyst . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
B.
Responsibilities of the Supervisor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
INVESTIGATING OOS TEST RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

A.
General Investigational Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
B.
Laboratory Phase of an Investigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
CONCLUDING THE INVESTIGATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

A.
Interpretation of Investigation Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
B.
Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Investigating Out of Specification (OOS) Test Results

for Pharmaceutical Production
I.
INTRODUCTION
This guidance for industry provides the Agencys current thinking on how to evaluate suspect,
or out of specification (OOS), test results. For purposes of this document, the term OOS results
includes all suspect results that fall outside the specifications or acceptance criteria established
in new drug applications, official compendia, or by the manufacturer.
This guidance applies to laboratory testing during the manufacture of active pharmaceutical
ingredients, excipients, and other components and the testing of finished products to the extent
that current good manufacturing practices (CGMP) regulations apply (21 CFR parts 210 and
211). Specifically, the guidance discusses how to investigate suspect, or OOS test results,
including the responsibilities of laboratory personnel, the laboratory phase of the investigation,
additional testing that may be necessary, when to expand the investigation outside the
laboratory, and the final evaluation of all test results.
II.
BACKGROUND
FDA considers the integrity of laboratory testing and documentation records to be of fundamental
importance during drug manufacturing. Laboratory testing, which is required by the CGMP
regulations ( 211.165), is necessary to confirm that components, containers and closures, in-process
materials, and finished products conform to specifications, including stability. Testing
This guidance has been prepared by the Office of Compliance/Division of Manufacturing and Product Quality,
Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. This guidance document
represents the Agencys current thinking on evaluating OOS test results. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute, regulations, or both.
also supports analytical and process validation efforts. General CGMP regulations covering
laboratory operations can be found in part 211, subparts I (Laboratory Controls) and J (Records
and Reports). These regulations provide for the establishment of scientifically sound and
appropriate specifications, standards, and test procedures that are designed to ensure that
components and containers of drug products conform to the established standards. Section
211.165(f) of the CGMP regulations specifies that products that fail to meet established
standards and other relevant quality control criteria will be rejected.
III.
IDENTIFYING AND ASSESSING OOS TEST RESULTS
FDA regulations require that an investigation be conducted whenever an OOS test result is
3
obtained. The purpose of the investigation is to determine the cause of the OOS. Even if a batch is
rejected based on an OOS result, the investigation is necessary to determine if the result is associated
with other batches of the same drug product or other products. Batch rejection does not negate the
need to perform the investigation. The regulations require that a written record of the investigation be
made including the conclusions of the investigation and follow-up (211.192).
To be meaningful, the investigation should be thorough, timely, unbiased, well-documented, and
scientifically defensible. The first phase of such an investigation should include an initial
assessment of the accuracy of the laboratory's data, before test solutions are discarded, whenever
possible. This way, hypotheses regarding laboratory error or instrument malfunctions may be tested
using the same test solutions. If this initial assessment indicates that no errors were made in the
analytical process used to arrive at the data, a complete failure investigation should follow.
A.
Responsibility of the Analyst
The first responsibility for achieving accurate laboratory testing results lies with the
analyst who is performing the test. The analyst should be aware of potential problems
that could occur during the testing process and should watch for problems that could
create OOS results.
In accordance with the CGMP regulations ( 211.160 (b)(4)), the analyst should ensure
2 Specifications must be scientifically sound and appropriate (21 CFR 211.160(b)), and test procedures must be
validated as to their accuracy, reliability, and suitability under actual conditions of use (21 CFR 211.194(a)(2)). For
products that are the subjects of NDAs, ANDAs, or INDs, specifications are contained in the application. Specifications
for non-application products may be found in official compendia, or established by the manufacturer.
Although the subject of this document is OOS results, much of the guidance may be useful for
examining results that are out of trend.
3
that only those instruments meeting established specifications are used and that
all instruments are properly calibrated.
Certain analytical methods have system suitability requirements, and systems not
meeting such requirements should not be used. For example, in chromatographic
systems, reference standard solutions may be injected at intervals throughout
chromatographic runs to measure drift, noise, and repeatability. If reference standard
responses indicate that the system is not functioning properly, all of the data collected
during the suspect time period should be properly identified and should not be used. The
cause of the malfunction should be identified and corrected before a decision is made
whether to use any data prior to the suspect period.
Before discarding test preparations or standard preparations, analysts should check
the data for compliance with specifications. When unexpected results are obtained
and no obvious explanation exists, test preparations should be retained and the
analyst should inform the supervisor. An assessment of the accuracy of the results
should be started immediately.
If errors are obvious, such as the spilling of a sample solution or the incomplete transfer
of a sample composite, the analyst should immediately document what happened.
Analysts should not knowingly continue an analysis they expect to invalidate at a later
time for an assignable cause (i.e., analyses should not be completed for the sole purpose
of seeing what results can be obtained when obvious errors are known). These same
responsibilities extend to analysts at contract testing laboratories.
B.
Responsibilities of the Supervisor
Once an OOS result has been identified, the supervisor's assessment should be objective
and timely. There should be no preconceived assumptions as to the cause of the OOS
result. Data should be assessed promptly to ascertain if the results may be attributed to
laboratory error, or whether the results could indicate problems in the manufacturing
process. An immediate assessment could include re-examination of the actual solutions,
test units, and glassware used in the original measurements and preparations, which
would allow more credibility to be given to laboratory error theories.
The following steps should be taken as part of the supervisor's assessment:
1.
Discuss the test method with the analyst; confirm analyst knowledge of
and performance of the correct procedure.
2.
Examine the raw data obtained in the analysis, including chromatograms

and spectra, and identify anomalous or suspect information.
3.
Confirm the performance of the instruments.
4.
Determine that appropriate reference standards, solvents, reagents, and

other solutions were used and that they meet quality control specifications.
5.
Evaluate the performance of the testing method to ensure that it is performing

according to the standard expected based on method validation data.
6.
Document and preserve evidence of this assessment.
The assignment of a cause for OOS results will be greatly facilitated if the retained
sample preparations are examined promptly. Hypotheses regarding what might have
happened (e.g. dilution error, instrument malfunction) can be tested. Examination of the
retained solutions can be performed as part of the laboratory investigation.
Examples:
!
Solutions can be re-injected as part of an investigation where a transient

equipment malfunction is suspected. This could occur if bubbles were introduced
during an injection on a chromatographic system, which other tests indicated was
performing properly. Such theories are difficult to prove. However, a reinjection
can provide strong evidence that the problem should be attributed to the
instrument, rather than the sample or its preparation.
For release rate testing of certain specialized dosage forms, where possible,
examination of the dosage unit tested might determine whether it was damaged
in a way that affected its performance. Such damage would provide evidence to
invalidate the OOS test result, and a retest would be indicated.
Further extraction of a dosage unit can be performed to determine whether it was

fully extracted during the original analysis. Incomplete extraction could
invalidate the test results and should lead to questions regarding validation of the
test method.
It is important that each step in the investigation be fully documented. The supervisor
should ascertain not only the reliability of the individual value obtained, but also the
significance these OOS results represent in the overall quality assurance program.
4
Supervisors should be especially alert to developing trends.

Laboratory error should be relatively rare. Frequent errors suggest a problem that might
be due to inadequate training of analysts, poorly maintained or improperly calibrated
equipment, or careless work. Whenever laboratory error is identified, the firm should
determine the source of that error and take corrective action to ensure that it does not
occur again. To ensure full compliance with the CGMP regulations, the manufacturer
also should maintain adequate documentation of the corrective action.
In summary, when clear evidence of laboratory error exists, laboratory testing results
should be invalidated. When evidence of laboratory error remains unclear, a failure
investigation should be conducted to determine what caused the unexpected results. It
should not be assumed that failing test results are attributable to analytical error without
performing and documenting an investigation. Both the initial laboratory assessment
and the following failure investigation should be documented fully.
IV.
INVESTIGATING OOS TEST RESULTS
When the initial assessment does not determine that laboratory error caused the OOS result and
testing results appear to be accurate, a full-scale failure investigation using a predefined
procedure should be conducted. The objective of such an investigation should be to identify the
source of the OOS result. Varying test results could indicate problems in the manufacturing
process, or result from sampling problems. Such investigations present a challenge both to
employees and to management and should be given the highest priority.
The investigation should be conducted by the quality control unit and should involve all
other departments that could be implicated, including manufacturing, process development,
maintenance, and engineering. Other potential problems should be identified and
investigated. The records and documentation of the manufacturing process should be fully
investigated to determine the possible cause of the OOS results.
A.
General Investigational Principles
A failure investigation should consist of a timely, thorough, and well-documented review.

The written record should reflect that the following general steps have been taken.
1.
The reason for the investigation has been clearly identified.
2.
The manufacturing process sequences that may have caused the problem should be
summarized.
3.
Results of the documentation review should be provided with the assignment

of actual or probable cause.
4.
A review should be made to determine if the problem has occurred previously.
5.
Corrective actions taken should be described.
The general review should include a list of other batches and products possibly affected
and any required corrective actions taken including any comments and signatures of
appropriate production and quality control personnel regarding any material that may
have been reprocessed after additional testing.
B.
Laboratory Phase of an Investigation
A number of practices are used during the laboratory phase of an investigation.

These include: (1) retesting a portion of the original sample, (2) testing a specimen
from the collection of a new sample from the batch, (3) resampling testing data, and
(4) using outlier testing.
1.
Retesting
Part of the investigation may involve retesting of a portion of the original sample. The
sample used for the retesting should be taken from the same homogeneous material that
was originally collected from the lot, tested, and yielded the OOS results. For a liquid, it
may be from the original unit liquid product or composite of the liquid product; for a
solid it may be an additional weighing from the same sample composite that had been
prepared by the analyst.
Situations where retesting is indicated include investigating testing instrument
malfunctions or to identify a possible sample handling integrity problem, for example, a
suspected dilution error. Generally, retesting is neither specified nor prohibited by
approved applications or by the compendia. Decisions to retest should be based on the
objectives of the testing and sound scientific judgment. Retesting should be performed
by an analyst other than the one who performed the original test.
The CGMP regulations require the establishment of specifications, standards, sampling
plans, test procedures, and other laboratory control mechanisms ( 211.160). The
establishment of such control mechanisms for examination of additional specimens for
6
commercial or regulatory compliance testing must be in accordance with "predetermined

guidelines or sampling strategies" (USP 23, General Notices and Requirements, p.9).
Some firms have used a strategy of repeated testing until a passing result is obtained
(testing into compliance), then disregarding the OOS results without scientific
justification. Testing into compliance is objectionable under the CGMPs. The number of
retests to be performed on a sample should be specified in advance by the firm in the
SOP. The number may vary depending upon the variability of the particular test method
employed, but should be based on scientifically sound, supportable principles. The
number should not be adjusted depending on the results obtained. The firm's
predetermined testing procedures should contain a point at which the testing ends and the
product is evaluated. If, at this point, the results are unsatisfactory, the batch is suspect
and must be rejected or held pending further investigation
( 211.165(f)).
In the case of a clearly identified laboratory error, the retest results would substitute
for the original test results. The original results should be retained, however, and an
explanation recorded. This record should be initialed and dated by the involved
persons and include a discussion of the error and supervisory comments.
If no laboratory or statistical errors are identified in the first test, there is no scientific
basis for invalidating initial OOS results in favor of passing retest results. All test results,
both passing and suspect, should be reported and considered in batch release decisions.
2.
Resampling
While retesting refers to analysis of the original sample, resampling involves analyzing a
specimen from the collection of a new sample from the batch. The establishment of
control mechanisms for examination of additional specimens for commercial or
regulatory compliance testing should be in accordance with predetermined procedures
and sampling strategies ( 211.165(c)).
In some cases, when all data have been examined, it may be concluded that the original
sample was prepared improperly and was therefore not representative of the batch
( 211.160(b)(3)). A resampling of the batch should be conducted if the investigation
shows that the original sample was not representative of the batch. This would be indicated,
for example, by widely varied results obtained from several aliquots of the original
composite (after determining there was no error in the performance of the analysis).
Resampling should be performed by the same qualified, validated methods that were used
for the initial sample. However, if the investigation determines that the initial
7
sampling method was in error, a new accurate sampling method must be

developed, qualified, and documented ( 211.160 and 165(c)).
3.
Averaging
Averaging test data can be a valid approach, but its use depends upon the sample and its
purpose. For example, in an optical rotation test, several discrete measurements are
averaged to determine the optical rotation for a sample, and this average is reported as
the test result. If the sample can be assumed to be homogeneous (i.e., an individual
sample preparation designed to be homogeneous), using averages can provide a more
accurate result. In the case of microbiological assays, the USP prefers the use of averages
because of the innate variability of the biological test system.
Reliance on averages has the disadvantage of hiding variability among individual test
results. For this reason, unless averaging is specified by the test method or adequate
written investigation procedures, all individual test results should be reported. In some
cases, a statistical treatment of the variability of results should be reported. For
example, in a test for dosage form content uniformity, the standard deviation (or
relative standard deviation) is also reported.
Averaging also can conceal variations in the different portions of the sample. For
example, the use of averages is inappropriate when performing powder blend/mixture
uniformity or dosage form content uniformity determinations. In these cases, the testing
is intended to measure variability within the product, and the individual results should be
reported.
It should be noted that a test might consist of replicates to arrive at a result. For instance,
an HPLC assay result may be determined by averaging the peak responses from a
number of consecutive, replicate injections from the same preparation (usually 2 or 3).
The assay result would be calculated using the peak response average. This
determination is considered one test and one result. This is a distinct difference from the
analysis of different portions from a lot, intended to determine variability within the lot.
The use of replicates should be included in the written, approved, test methodology.
Unexpected variation in replicate determinations should trigger investigation and
documentation requirements (21 CFR 211.192).
In some cases, a series of assay results may be a part of the test procedure. If some of the
results are OOS and some are within specification and all are within the documented
variation of the method, the passing results should be given no more credence than the
failing results, in the absence of documented evidence that analytical error had occurred.
8
Relying on test data averaging in such a case can be particularly misleading. For
example, in an assay with a given range of 90 to 110 percent, test results of 89 percent,
89 percent, and 92 percent would produce an average of 90 percent even though two of
the assay values represent failing results.
To use averaged results for assay reporting, all test results should conform to
specifications. Although the above average of 90 percent may be useful in terms of an
overall assessment of process capabilities, the individual assay results indicate
nonconformance because two of the three results are outside of the range. A low assay
value should also trigger concerns that the batch was not formulated properly because
the batch must be formulated with the intent to provide not less than 100 percent of the
labeled or established amount of active ingredient (21 CFR 211.101(a)). The above
example does not necessarily require the manufacturer to fail the batch, but indicates
that an immediate investigation should be conducted for batch disposition decisions.
4.
Outlier Tests
The CGMP regulations require that statistically valid quality control criteria include
appropriate acceptance and/or rejection levels ( 211.165(d)). On rare occasions, a value
may be obtained that is markedly different from the others in a series obtained using a
validated method. Such a value may qualify as a statistical outlier. An outlier may result
from a deviation from prescribed test methods, or it may be the result of variability in
the sample. It should never be assumed that the reason for an outlier is error in the
testing procedure, rather than inherent variability in the sample being tested.
Outlier testing is a statistical procedure for identifying from an array those data that are
extreme. The possible use of outlier tests should be determined in advance. This should
be written into SOPs for data interpretation and be well documented. The SOPs should
include the specific outlier test to be applied with relevant parameters specified in
advance. The SOPs should specify the minimum number of results required to obtain a
statistically significant assessment from the specified outlier test.
For biological assays having a high variability, an outlier test may be an appropriate
statistical analysis to identify those results that are statistically extreme observations. The
USP describes outlier tests in the section on Design and Analysis of Biological Assays
(USP 23, p. 1705). In these cases, the outlier observation is omitted from calculations.
The USP also states that "arbitrary rejection or retention of an apparently aberrant
response can be a serious source of bias. . .the rejection of observations solely on the
basis of their relative magnitudes is a procedure to be used sparingly" (USP 23, p. 1705).
For validated chemical tests with relatively small variance, and if the sample being
tested can be considered homogeneous (for example, an assay of composited dosage
form to determine strength), an outlier test is only a statistical analysis of the data
obtained from testing and retesting. It will not identify the cause of an extreme
observation and, therefore, should not be used to invalidate the data. An outlier test may
be useful as part of the evaluation of the significance of that result for batch evaluation,
along with other data.
Outlier tests have no applicability in cases where the variability in the product is what is
being assessed, such as for content uniformity, dissolution, or release rate determinations.
In these applications, a value perceived to be an outlier may in fact be an accurate result
of a nonuniform product.
V.
CONCLUDING THE INVESTIGATION
To conclude the investigation, the results should be evaluated, the batch quality should be
determined, and a release decision should be made. The SOPs should be followed in arriving
at this point. Once a batch has been rejected, there is no limit to further testing to determine
the cause of the failure so that a corrective action can be taken.
A.
Interpretation of Investigation Results
An OOS result does not necessarily mean the subject batch fails and must be rejected.
The OOS result should be investigated, and the findings of the investigation, including
retest results, should be interpreted to evaluate the batch and reach a decision regarding
release or rejection ( 211.165).
In those instances where an investigation has revealed a cause, and the suspect result is
invalidated, the result should not used to evaluate the quality of the batch or lot.
Invalidation of a discrete test result may be done only upon the observation and
documentation of a test event that can reasonably be determined to have caused the
OOS result.
In those cases where the investigation indicates an OOS result is caused by a factor
affecting the batch quality (i.e., an OOS result is confirmed), the result should be used in
evaluating the quality of the batch or lot. A confirmed OOS result indicates that the
batch does not meet established standards or specifications and should result in the
batch's rejection, in accordance with 211.165(f), and proper disposal.
10
For inconclusive investigations in cases where an investigation (1) does not reveal a
cause for the OOS test result and (2) does not confirm the OOS result the OOS result
should be retained in the record and given full consideration in the batch or lot
disposition decision.
Statistical treatments of data should not be used to invalidate a discrete chemical test
result. In very rare occasions and only after a full investigation has failed to reveal the
cause of the OOS result, a statistical analysis may be valuable as one assessment of the
probability of the OOS result as discordant, and for providing perspective on the result
in the overall evaluation of the quality of the batch.
Records must be kept of complete data derived from all tests performed to ensure
compliance with established specifications and standards (21 CFR 211.194).
B.
Reporting
For those products that are the subject of applications, regulations require submitting
within three working days a field alert report (FAR) of information concerning any
failure of a distributed batch to meet any of the specifications established in an
application (21 CFR 314.81(b)(1)(ii). OOS test results not invalidated on distributed
batches or lots for this class of products are considered to be one kind of information
concerning any failure described in this regulation. This includes OOS results that are
considered to be discordant and of low value in batch quality evaluation. In these cases,
an FAR should be submitted.
11

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Investigating Out of Specification

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IDENTIFYING AND ASSESSING OOS TEST RESULTS . . . . . . . . . . . . . . . . . . . . . 2

Responsibility of the Analyst . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Responsibilities of the Supervisor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

INVESTIGATING OOS TEST RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

General Investigational Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Laboratory Phase of an Investigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

CONCLUDING THE INVESTIGATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Interpretation of Investigation Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

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Investigating Out of Specification (OOS) Test Results

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IDENTIFYING AND ASSESSING OOS TEST RESULTS

Responsibility of the Analyst

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Responsibilities of the Supervisor

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Examine the raw data obtained in the analysis, including chromatograms

Confirm the performance of the instruments.

Determine that appropriate reference standards, solvents, reagents, and

Evaluate the performance of the testing method to ensure that it is performing

Document and preserve evidence of this assessment.

Solutions can be re-injected as part of an investigation where a transient

Further extraction of a dosage unit can be performed to determine whether it was

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Supervisors should be especially alert to developing trends.

INVESTIGATING OOS TEST RESULTS

General Investigational Principles

A failure investigation should consist of a timely, thorough, and well-documented review.

The reason for the investigation has been clearly identified.

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Results of the documentation review should be provided with the assignment

A review should be made to determine if the problem has occurred previously.

Corrective actions taken should be described.

Laboratory Phase of an Investigation

A number of practices are used during the laboratory phase of an investigation.

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commercial or regulatory compliance testing must be in accordance with "predetermined

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sampling method was in error, a new accurate sampling method must be

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CONCLUDING THE INVESTIGATION

Interpretation of Investigation Results

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